Regulatory Goes Digital: Chapter 5 in Our Series on Drug Development Data
In the final chapter of our series, Yash dives into one of the biggest upcoming shifts in drug development’s data paradigm: moving to structured, cloud-based regulatory submissions.
Welcome, Joschka Buyel: Longtime Customer, Now Our Director of Product Management
Joschka’s role will be a new chapter in his career as a multi-modal CMC expert—as well as a whole new way to apply his first-hand experience deploying and using our product.
Ready for AI to Transform CMC? Here’s How It Could Happen
With the right structured data, drug developers may be able to unlock incredible value with ML, NLP, LLMs, and more. Here’s what applied AI could look like for CMC.
Getting Started: What You Need in a PLM System for Digital CMC
Considering a pre-commercial PLM system for your drug development cycle? Here’s what to know about these evolving solutions, and what to look for in a specialized SaaS solution.
Conversation Starter: How To Convince Your Boss That Digital CMC Is Right for Your Team
Experts on the CMC data frontlines are quick to see the value of Digital CMC, but leadership might need some convincing. Here’s how to do it.
Data Governance and Integrity: Pharma, Biotech, and the Data Deluge, Part 4
In chapter 4 of our series on drug development data, Yash looks at a practical application of structured data principles: building a digital qTPP that supports automation of numerous CMC tasks.
Enabling Pre-commercial Product Lifecycle Management (PLM) for Pharma & Biotech
For drug developers, pre-commercial product lifecycle management (PLM) is quickly becoming essential for regulatory compliance and operational efficiency. Learn how digital CMC tools can enable it.
Getting Leaner, Going Digital: 4 Ways Drug Developers Are Adapting to a New Market
Drug developers are downsizing their way into a new era of efficiency. Here’s why they need digital infrastructure like QbDVision more than ever.
Data Governance and Integrity: Pharma, Biotech, and the Data Deluge, Part 3
Scrambling to consolidate CMC data often feels like a rite of passage for drug developers. But does it have to be that way? In post 3 of our series on data governance and integrity, Yash shares a modern, structured approach to managing CMC data.
New Updates to the FDA’s PAI Process Put Drug Developers on Notice
With the new CPMG Objective 4, the FDA has officially put knowledge management and QRM on the menu for PAI audits. So what does that mean for drug development programs?